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Brigatinib (Alunbrig) for Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer - Details

Project Number pCODR 10230
Brand Name Alunbrig
Generic Name Brigatinib
Tumour Type Lung
Indication Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer
Funding Request For the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) previously untreated with an ALK inhibitor.
Review Status Pending
Pre Noc Submission Yes
NOC Date
Manufacturer Takeda Canada Inc.
Sponsor Takeda Canada Inc.
Submission Date (Target Date) September 30, 2020
Submission Deemed Complete
Submission Type New Indication
Prioritization Requested
Stakeholder Input Deadline (target date based on target submission date) ‡ October 15, 2020
Check-point meeting (target date)
pERC Meeting (target date)
Initial Recommendation Issued (target date)
Feedback Deadline (target date) ‡
pERC Reconsideration Meeting (target date)
Final Recommendation Issued (target date)
Notification to Implement Issued

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.